MAUDE Adverse Event Report: COOK INC PERFORMER MULLINS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported during an unspecified procedure that while using a performer mullins guiding sheath the physician felt the sheath was bent however he still attempted to use it.During insertion, the hub separated.Another device from the same lot was pulled off the shelf and was visibly noted to be bent.The device was removed from the packaging and during examination, the hub easily separated.A third device was then used to complete the procedure.There were no reported adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The sheaths of the two performer mullins guiding sheath were not returned.Two dilators were returned with both hubs separated.Three kinks were present in each dilator shaft.Flare for both the devices were measured.Device #1: flare out of round.Wide diameter = 6.5mm, narrow diameter = 5.4 mm.Device#2: flare out of round.Wide diameter = 6.2mm, narrow diameter = 5.2 mm.The i.D of the connector cap accepted a maximum pin gauge of 0.196" whereas the maximum pin gauge that it is supposed to accept is 0.194".Since, the devices appeared to be damaged before the physician could use it, we cannot confirm whether the device was built out of specification.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the available information, it is likely that the device got damaged during shipping as the physician noticed the bent on the sheath before the procedure however the physician is instructed to inspected the product to ensure no damage has occurred.Therefore it is feasible to suggest two root causes of this failure: (1) package handling related and (2) it should also be noted that the user should not have attempted to use a defective device that was noticed before patient contact.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: PERFORMER MULLINS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6615485
• Report Number: 1820334-2017-01058
• Device Sequence Number: 649678
• Product Code: DYB
• UDI-Device Identifier: 00827002092105
• UDI-Public: (01)00827002092105(17)190913(10)7268222
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RCFW-14.0-38-75-RB-MTS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1